Prineo (Dermabond Protape) Versus Sutures for Full-thickness Surgical Incisions

• Sponsor: Ethicon, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00557947
• Collaborator: (none)
• Enrollment: 83
• Locations: 5
• Arms: 2
• Duration (Months): 20
• Patients Per Site: 16.6
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This is a prospective, controlled, randomized, multi-center clinical study of up to 80 subjects with full thickness surgical incisions. Each incision included in the study will be segmented into two halves; each half will be randomized to receive final skin closure with either Prineo (DERMABOND PROTAPE) or intradermal sutures. Subjects will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days).

Condition or Disease	Intervention/Treatment	Phase
Surgical Incisions	Device: Suture; Device: Dermabond Protape (Prineo)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multi-centre Study to Show Equivalence of Prineo (Dermabond Protape) to Intradermal Sutures for Skin Closure of Full-thickness Surgical Incisions
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I Dermabond Protape-Incision segments are randomized & patient is own control	Device: Dermabond Protape (Prineo); cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive; Other Names: Prineo
Active Comparator: II Intradermal Suture - Incision segments are randomized & patient is own control. Investigator selected suture on the basis of standard local practice.	Device: Suture; intradermal and topical suturing; Other Names: Investigator selected the intradermal suture per standard local practice.

Outcome Measures

Primary Outcome Measures

1. Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups. [12-25 days post-operation]

   Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.

Secondary Outcome Measures

1. Time Required to Close the Final Skin Layer [Intraoperative]

   Time to close final skin layer for each incision segment.

2. Cosmetic Outcome [90 days post-procedure]

   Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.

3. Cosmetic Outcome [6 months]

   Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.

4. Cosmetic Outcome [12 month]

   Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Be at least 18 years of age;

• Be in good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications;

• Be scheduled for at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty or body lift procedures, requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure;

• Be willing to follow instructions for incision care as instructed by the investigator, and refrain from swimming or soaking in a tub during the first 12 - 25 days of the study;

• Agree to return for all follow-up evaluations specified in this protocol [7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days)], six (± 1 month) and twelve months (± 1 month)];

• Agree not to schedule any additional elective surgical procedures that involve an incision that is randomized for inclusion in this study, until their participation in this study is complete; and

• Sign the informed consent.

Exclusion Criteria:

• Have peripheral vascular disease;

• Have insulin dependent diabetes mellitus;

• Be known to have a blood clotting disorder;

• Be receiving antibiotic therapy for pre-existing condition or infection;

• Be known to be HIV-positive or otherwise immunocompromised;

• Have known personal or family history of keloid formation or hypertrophy;

• Be currently taking systemic steroids;

• Have known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives

• Have incision type or location known to have an incidence of cyanosis or other healing abnormalities; and

• Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrolment in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ	Gent		Belgium
2	Dreifaltigkeits-Krankenhaus	Cologne		Germany
3	Markus Krankenhaus	Frankfurt		Germany
4	Akademikliniken	Stockholm		Sweden
5	Mid Essex Hospital	Broomfield	Essex	United Kingdom

Sponsors and Collaborators

• Ethicon, Inc.

Investigators

• Study Director: Helen Colquhoun, MD, Pleiad Devices

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ethicon, Inc.
• ClinicalTrials.gov Identifier: NCT00557947
• Other Study ID Numbers: 06CS005
• First Posted: Nov 14, 2007
• Last Update Posted: Jul 19, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Ethicon, Inc.: Abdominoplasty; Body Lift; Plastic Surgery; Skin Closure; Wound Healing; Dermabond
• Additional relevant MeSH terms: Surgical Wound

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from the general population undergoing elective surgical procedures for body contouring.

Arm/Group Title	Dermabond Protape/Suture
Arm/Group Description	Dermabond Protape-Incision segments are randomized & patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
Period Title: Overall Study
STARTED	83
COMPLETED	83
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Dermabond Protape/Suture
Arm/Group Description	Dermabond Protape-Incision segments are randomized & patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
Overall Participants	83
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	74 89.2%
>=65 years	9 10.8%
Sex: Female, Male (Count of Participants)
Female	77 92.8%
Male	6 7.2%
Region of Enrollment (participants) [Number]
Belgium	22 26.5%
Germany	36 43.4%
United Kingdom	20 24.1%
Sweden	5 6%

Outcome Measures

1. Primary Outcome

Title	Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.
Description	Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.
Time Frame	12-25 days post-operation

Outcome Measure Data

Analysis Population Description

The primary analysis is based upon intent to treat population.

Arm/Group Title	Dermabond Protape	Suture
Arm/Group Description	Dermabond Protape-Incision segments are randomized & patient is own control	Suture - Incision segments are randomized & patient is own control.
Measure Participants	83	83
Number [Participants]	74 89.2%	78 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dermabond Protape, Suture
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.
Statistical Test of Hypothesis	p-Value	0.2188
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	difference proportions of successes (%)
	Estimated Value	4.8
	Confidence Interval	(2-Sided) 95%; -0.0 to 10.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	The level of significance for statistical testing was 0.05 for this study.

2. Secondary Outcome

Title	Time Required to Close the Final Skin Layer
Description	Time to close final skin layer for each incision segment.
Time Frame	Intraoperative

Outcome Measure Data

Analysis Population Description

The analysis is based upon the Intent To Treat population

Arm/Group Title	Dermabond Protape	Suture
Arm/Group Description	Dermabond Protape-Incision segments are randomized & patient is own control	Suture - Incision segments are randomized & patient is own control.
Measure Participants	83	83
Mean (Standard Deviation) [minutes]	1.46 (0.96)	6.65 (4.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dermabond Protape, Suture
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Cosmetic Outcome
Description	Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.
Time Frame	90 days post-procedure

Outcome Measure Data

Analysis Population Description

There were 50 participants who consented to and ultimately attended follow-up visits for evaluation of cosmetic outcome.

Arm/Group Title	Dermabond Protape	Suture
Arm/Group Description	Dermabond Protape-Incision segments are randomized & patient is own control	Suture - Incision segments are randomized & patient is own control.
Measure Participants	50	50
Number [Incisions with good outcome]	33	37

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dermabond Protape, Suture
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3877
	Comments
	Method	McNemar
	Comments

4. Secondary Outcome

Title	Cosmetic Outcome
Description	Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

There were 50 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.

Arm/Group Title	Dermabond Protape	Suture
Arm/Group Description	Dermabond Protape-Incision segments are randomized & patient is own control	Suture - Incision segments are randomized & patient is own control.
Measure Participants	50	50
Number [Incisions with good outcomes]	30	32

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dermabond Protape, Suture
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7539
	Comments
	Method	McNemar
	Comments

5. Secondary Outcome

Title	Cosmetic Outcome
Description	Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes. Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.
Time Frame	12 month

Outcome Measure Data

Analysis Population Description

There were 49 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.

Arm/Group Title	Dermabond Protape	Suture
Arm/Group Description	Dermabond Protape-Incision segments are randomized & patient is own control	Suture - Incision segments are randomized & patient is own control.
Measure Participants	49	49
Number [Incisions with good outcome]	33	32

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dermabond Protape, Suture
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.0000
	Comments
	Method	McNemar
	Comments

Adverse Events

Arm/Group Title	Dermabond Protape		Suture		Procedure		Unrelated
Arm/Group Description	Dermabond Protape-Incision segments are randomized & patient is own control		Suture - Incision segments are randomized & patient is own control.		Reported events per local regulatory requirements but not related to either device or procedure.
All Cause Mortality
	Dermabond Protape		Suture		Procedure		Unrelated
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Dermabond Protape		Suture		Procedure		Unrelated
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/83 (3.6%)		3/83 (3.6%)		11/83 (13.3%)		3/83 (3.6%)
Cardiac disorders
Chest Pain	0/83 (0%)	0	0/83 (0%)	0	0/83 (0%)	0	1/83 (1.2%)	1
Arrhythmia	0/83 (0%)	0	0/83 (0%)	0	1/83 (1.2%)	1	0/83 (0%)	0
General disorders
Necrosis	0/83 (0%)	0	1/83 (1.2%)	1	1/83 (1.2%)	1	0/83 (0%)	0
Infections and infestations
Infection	0/83 (0%)	0	0/83 (0%)	0	1/83 (1.2%)	1	0/83 (0%)	0
Infection	0/83 (0%)	0	1/83 (1.2%)	1	1/83 (1.2%)	1	0/83 (0%)	0
Infection	1/83 (1.2%)	1	1/83 (1.2%)	1	1/83 (1.2%)	1	0/83 (0%)	0
Breast Abcess	0/83 (0%)	0	0/83 (0%)	0	0/83 (0%)	0	1/83 (1.2%)	1
Injury, poisoning and procedural complications
Seroma	0/83 (0%)	0	1/83 (1.2%)	1	1/83 (1.2%)	1	0/83 (0%)	0
Procedural Complication (requiring removal of skin flap) due to congestion of blood supply	0/83 (0%)	0	0/83 (0%)	0	1/83 (1.2%)	1	0/83 (0%)	0
Wound Dehiscence	0/83 (0%)	0	0/83 (0%)	0	1/83 (1.2%)	1	0/83 (0%)	0
Wound Dehiscence	1/83 (1.2%)	1	1/83 (1.2%)	1	1/83 (1.2%)	1	0/83 (0%)	0
Wound Infection	1/83 (1.2%)	1	0/83 (0%)	0	1/83 (1.2%)	1	0/83 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastic Breast Cancer	0/83 (0%)	0	0/83 (0%)	0	0/83 (0%)	0	1/83 (1.2%)	1
Surgical and medical procedures
Wound Dehiscence	1/83 (1.2%)	1	0/83 (0%)	0	1/83 (1.2%)	1	0/83 (0%)	0
Seroma	0/83 (0%)	0	0/83 (0%)	0	1/83 (1.2%)	1	0/83 (0%)	0
Wound Necrosis	0/83 (0%)	0	0/83 (0%)	0	1/83 (1.2%)	1	0/83 (0%)	0
Fluid Overload	0/83 (0%)	0	0/83 (0%)	0	1/83 (1.2%)	1	0/83 (0%)	0
Hematoma	1/83 (1.2%)	1	1/83 (1.2%)	1	1/83 (1.2%)	1	0/83 (0%)	0
Vascular disorders
Hematoma	0/83 (0%)	0	0/83 (0%)	0	1/83 (1.2%)	1	0/83 (0%)	0
Other (Not Including Serious) Adverse Events
	Dermabond Protape		Suture		Procedure		Unrelated
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/83 (19.3%)		16/83 (19.3%)		24/83 (28.9%)		7/83 (8.4%)
Gastrointestinal disorders
Nausea	0/83 (0%)	0	0/83 (0%)	0	6/83 (7.2%)	83	0/0 (NaN)	0
Constipation	0/83 (0%)	0	0/83 (0%)	0	3/83 (3.6%)	3	6/83 (7.2%)	6
General disorders
Pain (General Disorders)	16/83 (19.3%)	16	16/83 (19.3%)	16	19/83 (22.9%)	19	0/83 (0%)	0
Injury, poisoning and procedural complications
Procedure Pain	4/83 (4.8%)	4	4/83 (4.8%)	4	5/83 (6%)	5	0/0 (NaN)	0
Psychiatric disorders
Insomnia	0/83 (0%)	0	0/83 (0%)	0	5/83 (6%)	5	0/0 (NaN)	0
Respiratory, thoracic and mediastinal disorders
Cough	0/83 (0%)	0	0/83 (0%)	0	4/83 (4.8%)	4	1/83 (1.2%)	1

Limitations/Caveats

Limitations of this study include the fact that the patient served as her own control. Additionally, as in many device studies, because of the obvious difference in the investigated and the control devices, blinding was limited.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.